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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-01-14~2015-02-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The guinea pig maximization test (GPMT) is already available for the registration outside of EU. Therefore, LLNA is not conducted.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report):Everdirect SH14(DBk112)
- Substance type:Powder
- Composition of test material, percentage of components:88.53%
- Lot/batch No.:4401
- Expiration date of the lot/batch:2016-10-31
- Storage condition of test material:Refrigeration(5 ± 3℃)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
For pilot study : 12%, 10%, 8% and 6%
For main study : 12%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
For pilot study : 12%, 10%, 8% and 6%
For main study : 12%
No. of animals per dose:
For pilot study : three
For main study : Control group:five ; Test group:ten

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
12% of test article
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No visible change
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 12% of test article. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No visible change.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
12% of test article
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible change
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12% of test article. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No visible change.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
12% of test article
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No visible change
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 12% of test article. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No visible change.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
12% of test article
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible change
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12% of test article. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No visible change.

Any other information on results incl. tables

Table 1 : Result of pilot study

Treatment

Animal ID.

Sex

Grade of skin reaction/Concentration of test article

24 hrs

48 hrs

12%

10%

8%

6%

12%

10%

8%

6%

Intradermal injection

01

Male

0

0

0

NA

0

0

0

NA

Epidermal application

02

Male

0

0

0

0

0

0

0

0

03

Male

0

0

0

0

0

0

0

0

Table 2 : The body weight of the guinea pigs

Group

Sex

Animal ID.

Animal Weight (g)

Weighy Change (g)

Day 1

Day 26

Control group

Male

391

356.6

503.4

+146.8

392

326.2

485.4

+159.2

393

343.8

506.4

+162.6

394

344.8

489.6

+144.8

395

341.8

500.8

+159.0

Test group

Male

396

337.4

494.6

+157.2

397

361.2

482.4

+121.2

398

367.8

522.0

+154.2

399

345.8

480.6

+134.8

400

366.8

507.4

+140.6

401

335.4

480.4

+145.0

402

343.8

496.6

+152.8

403

331.8

492.8

+161.0

404

351.8

520.8

+169.0

405

354.6

484.9

+130.3

Table 3 : Individual skin reaction of guinea pigs

Group

Sex

Animal ID.

Grade of skin reaction

Percent of Animals Sensitized

Sensitizing Capacity

24 hrs

48 hrs

Control group

Male

391

0

0

0%

Weak

392

0

0

393

0

0

394

0

0

395

0

0

Teat group

Male

396

0

0

0%

Weak

397

0

0

398

0

0

399

0

0

400

0

0

401

0

0

402

0

0

403

0

0

404

0

0

405

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
A challenge application was performed on the upper flank. Any skin reaction present in the treated areas was observed and recorded at 24 and 48 hours after the challenge. Results indicated that neither the test group nor the control group guinea pigs exhibited a hypersensitivity response on upper flank skin after application of the challenge does (0% sensitized).
Executive summary:

According to OECD Guideline 406 (Skin Sensitisation), this test article was classified as having weak allergenic potential. The test result is "not sensitising", so that hazard category in CLP is not classified.